Human Subject Research: International Supplemental Guidance

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Click here to download the International Supplemental Guidance Information

International Sites should follow this tiered plan subject to local health authority and local IRB direction.

It is strongly advised that investigators confer with and rely on local partners to ensure appropriate decision-making for your local context.

Definitions:

• Community transmission is evidenced by the inability to relate confirmed cases through chains of transmission for a large number of cases, or by increasing positive tests through sentinel samples (routine systematic testing of respiratory samples from established laboratories).
• Local transmission indicates locations where the source of infection is within the reporting location.
• Imported cases only indicates locations where all cases have been acquired outside the location of reporting.
• Under investigation indicates locations where type of transmission has not been determined for any cases.
• Interrupted transmission indicates locations where interruption of transmission has been demonstrated (details to be determined)

Please consult the following table regarding the WHO classifications of the pandemic: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/